Recognizing 2021 Black Maternal Health Week

April 12, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org(412) 945-3242 or Taun Sterling, tauns@nclnet.org(202) 207-2832

Washington, DC—The National Consumers League (NCL) applauds the resolution introduced by Representative Alma Adams, (NC-12), Representative Lauren Underwood (IL- 14), and Senator Cory Booker (D-NJ) designating April 11-17, 2021 as national Black Maternal Health Week.

The dismal state of maternal and infant health disparities in the United States continues to disproportionately impact black women and babies. In 2020, the rate of pre-term births—the second largest contributor to infant death in the United States—increased to 10.2 percent of births. Black women experience premature delivery at a rate 50 percent higher than all other American women. To address this disparity, in June 2020 NCL led a coalition of organizations in advocating for the FDA to protect patient access to a critical therapy for pregnant mothers at risk of recurrent preterm birth—lack of access to this therapy could disproportionately and negatively impact women of color.

NCL has long advocated for policies to improve maternal health outcomes and sought to address the persistent racial and ethnic health disparities that lead to adverse birth outcomes for black women. NCL is proud to support the Black Maternal Health Momnibus, a package of 12 bills intended to comprehensively address the maternal health crisis that disproportionately impacts Black, Indigenous, and women of color in this country. NCL also applauded a provision within the American Rescue Plan that allows states to extend Medicaid coverage to women for up to one year after childbirth. This provision to expand postpartum care is vital to improving maternal health outcomes for our most vulnerable moms.

“In order to address the maternal mortality crisis in this country, we need to recognize the link between structural racism and the social determinants of health that contribute to the disproportionately high rate of maternal mortality among Black women. This resolution designating Black Maternal Health Week is an important step in supporting policies to improve maternal health outcomes for Black Mamas,” said NCL Health Policy Director Jeanette Contreras.

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Jeanette Contreras portrait

PBMs profit while consumers foot the bill. Policymakers must act

By NCL Director of Health Policy Jeanette Contreras

As consumers, when we go to the pharmacy for our medications, we expect a fair price. However, there’s growing evidence that pharmacy benefit managers — or PBMs — have been impeding the savings that should be going to consumers. Consumers deserve  to share in the cost savings, and we need policymakers to step in and help make that happen.

We previously wrote about our disappointment in how PBMs have evolved from once honest brokers to becoming profit driven and greedy, now taking savings away from consumers and patients.

One avenue PBMs use to pocket savings is through pharmaceutical rebates. PBMs negotiate with companies to lock in discounts for drugs in order to secure the drugs’ placement on a list (formulary). PBMs have notoriously leveraged formularies to give greatest access to the drugs that pay the PBMs the largest rebates, leaving less expensive drugs off-limits to consumers.

A recent Senate Finance Committee report found that rebates to PBMs have significantly increased since 2013 (some as high as 70 percent). But these discounts fail to lower the patients’ out-of-pocket costs for necessary treatments, such as insulin. For one product, the manufacturer offered the PBM a 56 percent rebate – which means more than half of the savings for insulin are going to a company that doesn’t even make the lifesaving medication.

Insulin is expensive. Forbes recently reported that newer versions cost patients between $175 and $300 a vial. The story points out diabetes patients need multiple vials, the cost of which add up quickly; the total annual value of rebates and discounts for PBMs is likely to be more than $5,000 per patient. As a result, consumers lose, paying more than many of them can afford for lifesaving drugs.

Another way PBMs profit is by avoiding competition, which would drive value and savings for consumers. Three main PBMs accounted for about 60 percent of all U.S. prescription claims in 2019. And when it comes to insulin, with so few industry players, it’s no surprise that consumers again find themselves on the losing end.

We’re pleased to see that some policymakers in the states are taking steps to address these issues. In New Jersey, the state is shaking things up by creating alternatives to how it contracts with PBMs — which is, in turn, increasing competition and benefitting consumers. New Jersey residents are saving  a bundle (to the tune of $2.5 billion over five years).

In New Hampshire, a recent study shows that the state can expect to save an estimated $17.8-$22.2 million annually thanks to legislation that will utilize a similar competitive PBM contract process.

While this is encouraging news, there is still more work to be done to bring to light the role of PBMs. Policymakers need to step in to ensure PBMs deliver savings to patients as they were originally intended to do. We’re encouraging state and federal action to review the role PBMs play in driving up costs and to address the many loopholes they use to increase profits.

Consumers — not PBMs — should come first at the pharmacy counter. Reach out to your elected officials. Share this story on social media to help raise awareness. And stay tuned as we continue the conversation.

Jeanette Contreras portrait

Expanded Medicaid coverage for postpartum care

By NCL Director of Health Policy Jeanette Contreras

The COVID-19 pandemic has enlightened us to how the social determinants of health adversely impact maternal outcomes in low-income, medically underserved communities. Year after year, the United States continues to have the highest maternal mortality ratio among wealthy countries. In efforts to address this disparity, the American Rescue Plan Act includes a provision that allows states to expand Medicaid coverage to women for up to one year after childbirth.

The dismal maternal and infant mortality rates are directly correlated with the health disparities that disproportionately afflict black, indigenous, and women of color. A 2019 report from the Centers for Disease Control and Prevention (CDC) found that Black women were 3.3 times more likely than white women to die from pregnancy-related complications and Native American and Alaska Native women were 2.5 times more likely than white women to die within a year after childbirth.

Medicaid has traditionally been seen as a safety net for low-income pregnant women and children, providing health coverage that funds more than four in ten births in the U.S. each year. Under federal law, Medicaid must cover pregnant women with incomes up to 138 percent of the Federal Poverty Level (FPL) through 60 days postpartum. Each year, over 1.6 million women across the U.S. are effectively placed at risk for becoming uninsured when that 60-day coverage period ends.

Women who live in states that expanded Medicaid under the Affordable Care Act (ACA) are eligible to continue their health coverage through Medicaid. Additionally, the Families First Coronavirus Response Act, which passed last year, provides states with a 6.2 percent increase to the Federal Medical Assistance Percentage (FMAP) rate to cover new enrollees eligible under the ACA Medicaid expansion as long as the Public Health Emergency is in place or at least throughout 2021. However, the women living in the 14 states that have yet to expand Medicaid would find themselves uninsured.

Under the American Rescue Plan, for the next five years, states have the option to extend Medicaid and the Children’s Health Insurance Program (CHIP) eligibility to pregnant individuals for 12 months postpartum. Though each state’s Medicaid program is different, the inclusion of this provision incentivizes states to extend health care to mothers during the most vulnerable time in their lives. This increased access to health care will pave the way towards improving health disparities for our most at-risk women and infants beyond the pandemic.

Consumers face an unfair disadvantage at the pharmacy counter

By Sally Greenberg, NCL Executive Director

Everywhere we turn these days, we find ourselves wondering if we are getting a fair deal. Americans continue to suffer the economic consequences of a year-long global health pandemic, and many of us are trying to stick to the essentials and stretch our dollars where we can. As COVID-19 has reminded us, there aren’t many issues families face that are more significant than access to health care.

Families can’t go without essential prescriptions and often wonder why the price seems to go up each time they go for a refill. In fact, we are likely paying more than necessary at the pharmacy counter, but we don’t often know — or even think to ask — why.

A variety of factors drive drug costs, some of which are obvious: the cost of research and development, distributing the product, the pharmacies’ profits – but there is one far less known cause of price increases: PBMs, short for pharmacy benefit managers.

Most people have never heard of PBMs, and PBMs like it that way. They are billion-dollar companies that control more than 80 percent of the prescription drug formularies, (formularies are the lists of drugs that a health plan allows its members to access) — in the United States.

Because of their outsized role, too often PBMs determine how much consumers, businesses, government agencies, and others pay for medicines. As originally conceived, PBMs were meant to help ensure that patients get a fair deal by:

  • working with manufacturers to ensure rebates (or savings) for medications
  • working with insurance companies to determine which medications are covered
  • working with pharmacies to set the price points and help reimburse pharmacies for dispensing prescriptions.

In theory, PBMs should be lowering costs for everyone. However, as they have evolved and grown, they’ve become greedy and self-serving entities, scooping up discounts for themselves and throwing consumers under the bus. All the while, their profits continue to soar as they are all among the top Fortune 500 companies.

Sadly, PBMs have also found ways to manipulate the system and put their own profits first.

Insulin is a prime example. Diabetes patients who need their medication to survive are increasingly left with fewer options for treatment. When PBMs get involved, consumer costs increase.

One recent analysis found that the total value of rebates and discounts for insulin on an annual basis amounts to more than $5,000 per patient. Another report explained that the net price on one insulin product — what the company earns as revenue — declined by 53 percent since 2012, while the list price increased 141 percent. As the WSJ story explains, this is in part due to PBM middlemen meddling. In order to ensure formulary positions (which PBMs control), companies are paying more and more each year.

Consumers don’t know where high drug prices come from and they shouldn’t have to — the system needs to deliver affordable, accessible, safe and effective medications without any entities taking an unfair or hidden profit. The stakes are too high as we look ahead to the health challenges that millions face with the Covid pandemic.

NCL joins with many other groups, including America’s Agenda, United Food and Commercial Workers International Union, HMC Healthworks, Union of Bricklayers and Allied Craftworkers, National Community Pharmacists Association, National Alliance of State Pharmacy Associations, Diabetes Leadership Council, and Diabetes Patient Advocacy Coalition in helping to expose hidden, and frankly, indefensible profits being directed to the coffers of PBMs — money that should be redirected to bring drug prices down for patients and consumers.

Let’s all ask hard questions about PBMs’ role in our healthcare system and whether we can’t be using the profits they are taking to lower drug costs. Share this story with others. Talk with your friends and family. Ask your local pharmacist questions.

Consumers – not PBMs — should come first at the pharmacy counter. Stay tuned for more from us on this, and let’s continue the conversation.

National Consumers League applauds House passage of American Rescue Plan

March 10, 2021
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC—The National Consumers League (NCL) applauds the House of Representatives’ action to approve President Joe Biden’s relief package, known as the American Rescue Plan.

“The American Rescue Plan is a monumental relief package and critical antipoverty measure that will give desperately needed support to average Americans who have been devastated by COVID-19, including sending out $1,400 checks and funding states’ efforts to streamline and speed up vaccine distribution. This is a much-needed measure, and we are grateful to the Administration and Congress for their round-the-clock work in getting this essential support into the pockets of hard working Americans,” said NCL Executive Director Sally Greenberg.

With the 220-211 House vote, the bill will go to the President’s desk for signature. NCL applauded specific measures included in the legislation:

  • $300 federal boost to weekly jobless payments and extension of two key pandemic unemployment benefits programs through September 6.
  • Expansion of the child tax credit to up to $3,600 per child and $3,000 for each child under age 18 . Currently, families can receive a credit of up to $2,000 per child under age 17.
  • The first $10,200 worth of benefits payments are tax-free for households with annual incomes less than $150,000.
  • The Pandemic Unemployment Assistance program, which provides benefits to freelancers, gig workers, and independent contractors.
  • The Pandemic Emergency Unemployment Compensation program, which increases the duration of payments for those in the traditional state unemployment system.
  • $350 billion in relief to states, local governments, territories. and tribes.
  • $10 billion Coronavirus Capital Projects Fund.
  • 15 percent increase in food stamp benefits through September (it was previously set to expire at the end of June).
  • $880 million for the Special Supplemental Nutrition Program for Women, Infants, and Children, known as WIC, to help increase participation and temporarily improve benefits, among other measures.
  • $30 billion to help renters and landlords weather economic losses.

“It’s a great relief that passage of the bill comes ahead of a Sunday deadline, when a federal boost to unemployment benefits was set to expire,” said Greenberg.

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
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Jeanette Contreras portrait

La tercera vacuna trae esperanza

By NCL Director of Health Policy Jeanette Contreras

La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) acaba de aprobar una autorización de uso de emergencia para la vacuna de Johnson & Johnson, la tercera vacuna para combatir el coronavirus en EEUU. Aunque parece que no es tan efectiva como las otras dos, la vacuna de Johnson & Johnson ofrece una protección de 85 por ciento contra casos severos de COVID-19 y 100 por ciento de eficacia para evitar hospitalización y mortalidad, a causa del COVID-19. Con solo una dosis, esta vacuna ofrece protección de 72 por ciento contra el COVID-19 que ultimadamente ayuda controlar la pandemia en la población y alcanzar un nivel de inmunidad necesaria para regresar a la vida normal.

Una ventaja enorme de esta vacuna en términos de administración, es que se puede mantener en refrigeración normal por meses. Las otras vacunas requieren mantenimiento de temperatura súper baja en refrigeradores industriales que solo se encuentran en hospitales grandes. La vacuna de Johnson & Johnson es ideal para distribuir a comunidades rurales y en clínicas comunitarias. La aprobación de esta tercera vacuna, aumenta la disponibilidad y nos da esperanza de poder vacunar a más personas, más rápido con solo una dosis.

Sabemos que la comunidad Latina sufre de una taza de contagio más alta que otros grupos. Latinos constituyen una gran cantidad de empleados en trabajos esenciales con alto riesgo de contagio, como en la producción de comida y en puestos de trabajo de pequeños negocios. Mientras muchos esperan vacunarse, otros tendrán dudas o miedo de vacunarse. La campaña De Ti Depende nos asegura que es normal tener preguntas y ofrece información y respuestas en español para educar a la comunidad latina.

Campañas educativas como esta son necesaria para combatir información falsa y mitos que circulan en las redes sociales. Se escuchan mitos que las vacunas en general hacen daño o que alteran o cambian el ADN. Sin embargo, está comprobado científicamente por siglos que las vacunas han salvado vidas y nos han protegido. Los Centros para el Control y la Prevención de Enfermedades (CDC, por sus siglas en inglés) tiene una página dedicada a información para derribar los mitos más frecuentes acerca de estas vacunas.

Para alentar a la población a vacunarse, muchas empresas grandes están ofreciendo tiempo pagado o incentivos financieros a los empleados que se vacunan. Por ejemplo, supermercados como Publix les da $125 y Kroger les da $100 a empleados cuando reciben la vacuna completa. Dollar General les aumenta cuatro horas de pago normal a los que se vacunan.

Gracias a la autorización de la nueva vacuna, presidente Biden afirma que para el fin de mayo habrá vacunas para todos los adultos en EEUU. Las personas que deciden vacunarse, pueden buscar información confiable en el recurso de Telemundo – PlanificaTuVacuna.com para verificar la elegibilidad de acuerdo a las órdenes de cada estado.

Getting more vaccines in arms: Trust and efficiencies

Guest blog by Farah Towfic, PharmD, MBA, director of the U.S. Pharmacopeia COVID-19 Vaccine Handling Toolkit

In the United States, nearly 200 million doses of influenza vaccines are administered annually. Clearly, pharmacists, nurses, physicians, and other healthcare practitioners have demonstrated a successful track record of delivering robust immunization programs for many years. However, the unprecedented scale and speed at which the COVID-19 vaccinations must be delivered to curb the devastating impact of this pandemic has surfaced enormous challenges—which have been further compounded by significant vaccine supply demand.​ Never before have we had to distribute multiple doses to more than 15 billion individuals around the world, with more than 300 million in the U.S. alone.

The pandemic has also recharged the focus on vaccine hesitancy, a challenging and complex issue which, at its core, is about trust based on a person’s experience and perspective. According to the KFF COVID-19 Vaccine Monitor, a growing share of the public is open to getting vaccinated, but many of the same groups that were hesitant in December 2020, when the first COVID-19 vaccines were released, remain hesitant now. When deciding whether to get vaccinated, most people say they will likely turn to pharmacists, doctors, nurses, and healthcare providers as the source for information. The KFF COVID-19 Vaccine Monitor also notes that 85 percent of people trust their own doctor or healthcare provider at least a fair amount for reliable vaccine information.

If we are going to mitigate the impact of this pandemic, we need to help build and maintain trust in COVID-19 vaccines. As an independent, nonprofit, scientific organization, U.S. Pharmacopeia (USP) has been dedicated—for more than 200 years—to improving global health and building trust in medicine through public standards and related programs that help ensure the quality, safety, and benefit of our drugs. With our shared goals to provide patient access to quality medicines, USP is proud to be a founding member of the National Consumers League (NCL) Health Advisory Council. The Council’s informative communication and opportunities for engagement provide critical perspectives that help shape and inform USP’s strategic focus and initiatives. The Health Advisory Council also demonstrates the power of collaboration—which is a cornerstone of USP’s work.

By working together with stakeholders, partners in industry and the U.S. government, we are able to identify the COVID-19 vaccine operational challenges and also provide solutions. One of these solutions is the recently released USP COVID-19 Vaccine Handling Toolkit, which addresses gaps that slow getting shots in arms and helps healthcare practitioners safely deliver vaccines in a variety of settings.

As millions of additional doses of COVID-19 vaccines are released, the USP COVID-19 Vaccine Handling Toolkit is helping doctors, nurses, pharmacists, and other healthcare practitioners create operational efficiencies to vaccinate more people in their communities quickly and safely, all the while maintaining quality. It includes strategies in three key areas:

  • Preparation and labeling to support different practitioners preparing and administering vaccines including how to maximize the number of doses per vial and enabling pre-drawing of vaccines in advance of large immunization events.
  • Storing, handling, and transporting the vaccine to mass vaccination clinics, nursing and long-term care facilities, and more.
  • Waste prevention and disposal to support settings in preventing vaccine waste and addressing gaps for vaccine administrators in proper disposal of ancillary supplies, such as syringes.

“Using the strategies from the USP Vaccine Handling Toolkit for pre-drawing syringes and streamlining our processes and workflow we increased shots in arms by 50% per day,” says Patricia W. Slattum, Pharm.D., Ph.D., BCGP, a vaccine administrator with the Virginia Medical Reserve Corp and Virginia Commonwealth University.

More than 40 independent expert volunteers along with U.S. government representatives developed this toolkit that enables healthcare practitioners to benefit from consistent, scientific-based strategies developed by independent experts that close efficiency gaps across states and territories.

The USP COVID-19 Vaccine Handling Toolkit is one of several initiatives USP is undertaking to support quality and build trust in COVID-19 vaccines, treatments, and preventatives. For example, our Hand Sanitizer Toolkit, launched in spring 2020, is being used by many around the world to ensure quality preparation of this essential COVID-19 preventative.

As the nation’s pioneer consumer organization, that leads the charge on the importance of adherence to live-savings medicines, NCL plays a pivotal role in helping to build trust in vaccines. USP values the opportunity to share the COVID-19 Vaccine Handling Toolkit with NCL and looks ahead to future opportunities to partner with NCL and other stakeholders in the patient advocacy community.

As more is learned about COVID-19 vaccines, additional information will be shared in the future. We encourage NCL’s readers to sign-up for updates at https://www.usp.org/covid-19/vaccine-handling-toolkit.

About USP
USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. Through our standards, advocacy, and education, USP helps increase the availability of quality medicines, supplements, and food for billions of people worldwide.

NCL encourages HHS nominee Becerra to continue efforts to help lower consumer out-of-pocket costs at the pharmacy counter

March 1, 2021
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC—The National Consumers League is encouraging the Department of Health and Human Services (HHS) nominee Xavier Becerra to continue critical efforts to help drive down consumer out-of-pocket costs of medicines at the pharmacy counter.

Last week, Becerra testified before the Senate HELP Committee as his confirmation hearings were underway. If confirmed, Becerra would play a critical role in helping consumers pay no more than necessary for the medications they need by addressing the role pharmacy benefit managers (PBMs) play in determining what consumers pay and why.

NCL Executive Director Sally Greenberg weighed in with the following statement:

“PBMs have repeatedly promised to lower costs for patients, but unfortunately we’ve not seen this in action. When it comes to prescription drug access and affordability, we should all be on the side of consumers, rather than middlemen corporations. The challenges posed by COVID-19 serve as a daily reminder of the importance of standing up for individuals and families that don’t have the knowledge or patience to understand why they’re subjected to PBM schemes. If confirmed, Attorney General Becerra will have the opportunity to continue working on this issue and helping to ensure PBMs uphold their promise to consumers. Everyone in the health care system needs to work to reduce costs for consumers, who are burdened by high costs across the board. We look forward to joining with him to get to the heart of why out-of-pocket costs are rising and, most importantly, what can be done about it.”

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
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Jeanette Contreras portrait

Vaccine recommendations for those who recovered from COVID-19

By NCL Director of Health Policy Jeanette Contreras

As the United States prepares for the release of a third COVID-19 vaccine, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) meets to discuss further implementation considerations that will inform guidance for the vaccine rollout. At its March 1 meeting, ACIP dedicated a portion of the discussion to whether those who’ve recovered from the virus should still be vaccinated.

To date, there are more than 28 million confirmed cases of COVID-19, and experts estimate that the true number of individuals infected, yet not clinically confirmed, to be triple that amount, pushing the total prevalence to approximately 100 million. A recent study by the National Institutes of Health (NIH) indicates that those who’ve recovered will have a certain amount of natural immunity to the virus for up to eight months after infection, which is in line with the findings of a major British study published in early February, in which 88 percent of participants who previously tested positive for COVID-19 still had antibodies after six months.

Considering that the demand is greater than the supply, it is a difficult task to make recommendations for the equitable distribution of vaccines. For example, Spain issued recommendations that patients wait six months after diagnosis to get vaccinated if an individual is under age 55 with no major health complications. People over 55, or those with health risks that make them vulnerable to reinfection, are exempt from this delay and encouraged to be vaccinated.

Additionally, early studies are showing that immunity in individuals who had recovered and received one shot may be equal to or even exceed those not infected who had received two doses. According to the University of Maryland School of Medicine, a single dose of the Moderna or Pfizer mRNA vaccines would elicit an immune system response sufficient to provide comparable immunity to two doses in a non-infected person. On February 12, France became the first country to issue guidance recommending that people who have already recovered from COVID-19 only need to receive one dose of a vaccine, between 3 and 6 months after their infection.

Early research like this is informing public health policies in other countries. But the United States is known all over the world for its scientific rigor and reliance on randomized clinical trial data as a gold standard. In a recent blog, NIH Director Dr. Francis Collins reassures us that, should other studies support these early results, the experts at the Food and Drug Administration (FDA) and CDC will certainly consider whether one dose is enough.

The implementation of a one-dose vaccine would help to increase supply, however, the emergence of COVID-19 variants presents new challenges for curbing this pandemic. Current CDC guidance states that even if you’ve recovered from COVID-19, you should get vaccinated. Arming yourself with a vaccine will keep you and your family safe, and ultimately help to stave off new COVID-19 variants.

NCL testimony before FDA on Janssen Biotech COVID-19 vaccine

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

February 26, 2021

NCL’s Associate Director of Health Policy Nissa Shaffi testified before the FDA’s Vaccines and Related Biological Products Advisory Committee at the Center for Biologics Evaluation and Research. Read her testimony.

Hana El Sahly, M.D., Chair
Vaccines and Related Biological Products Advisory Committee
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993

RE: Docket No. FDA-2021-N-0173; for Vaccines and Related Biological Products Advisory Committee

Good Afternoon. I am Nissa Shaffi, present today on behalf of the National Consumers League. I have no conflicts of interest to disclose. Our organization extends its gratitude to the Vaccines and Related Biological Products Advisory Committee, for the opportunity to amplify consumer voices regarding the Janssen Biotech COVID-19 vaccine.

For over 120 years, NCL has championed efforts to increase vaccine education, safety, and access for consumers. As consumer advocates, we thank the Food and Drug Administration for their commitment to fostering public trust throughout the development and approval of a vaccine for COVID-19. We have been encouraged by the transparency and opportunities for engagement afforded to the public during this process.

Emergency Use Authorization (EUA)

Consumers are relying on the FDA more than ever for guidance pertaining to treatments for COVID-19, and preserving their confidence in the Agency is of vital importance at this time. Emergency Use Authorization, while not intended to replace randomized clinical trials, has been a critical component to the nation’s pandemic strategy. NCL appreciates the FDA’s recognition of clinical trials as vital to demonstrating the safety and efficacy of a treatment.

Safety and Effectiveness

We are encouraged by reports indicating that the Janssen Biotech vaccine has proven to be effective against hospitalizations and deaths from COVID-19. The added benefit of another vaccine is to decrease virus mutation. Presently, three, far more contagious, variants of COVID-19 spread and could hamper efforts to quell the virus. We are reassured that the Janssen vaccine has demonstrated efficacy against certain variants. As new data is collected, we call on the FDA to perform post-market surveillance to monitor ongoing efficacy.

Health Equity

Vaccine hesitancy and social determinants of health remain critical obstacles in the vaccine rollout process. The Janssen Biotech single-shot vaccine has the potential to increase access for hard-to-reach communities, bringing us closer to herd immunity. This week, we marked a grim milestone, as half a million Americans have now perished from this relentless virus. Amidst this loss, the continued development of vaccines for COVID-19 has provided the nation with much-needed hope and respite.

As the Committee deliberates on the Janssen Biotech COVID-19 vaccine, we request the Agency to also consider the benefit its release would have for historically disadvantaged communities, for which this vaccine would be logistically more accessible than the prior two vaccines.

Thank you to the Committee for your consideration of our views. Through our consumer education work, NCL will continue to support FDA in its efforts to develop a safe, effective, and expedited pathway towards a vaccine for COVID-19.

Sincerely,

Nissa Shaffi
Associate Director of Health Policy
National Consumers League

 

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
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